That is a question the U.S. Supreme Court will probably address this term (Ass’n for Molecular Pathology v. Myriad Genetics, Docket No. 12-398). Long-time Supreme Court watcher and reporter Lyle Denniston says the ruling could have broad implications for scientific research, but also for doctors’ treatment of some serious diseases.
Many women seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Myriad involves two human genes, BRCA-1 and -2, which are known to have genetic mutations that suggest a much higher risk of cancer (85%) in women. Health care professionals claim they need to know if a patient’s DNA contains any of these mutations when making clinical decisions. But Myriad, a private lab that also does genetic screening, has denied them access to BRCA-1 and -2, claiming that patents it obtained for a new process of screening them for mutations (“isolating”) give it exclusive ownership rights to the genes and all of their mutations.
The health care organizations challenging the patents’ validity argue that the lab’s claim is simply an attempt to "establish a monopoly over natural phenomena” and thus not subject to patent protection. The lab defends its ownership rights, claiming that its isolating process is a “product of human ingenuity” that is unique, with a distinctive name; character; and use.
Myriad’s patents have been upheld twice by the U.S. Court of Appeals for the Federal Circuit, the specialized appeals court for patent disputes.
